Impact
Assessment
&
Human Rights
Screening
Tool
Policy for Commissioning of Excision of Uterus
(abdominal or vaginal)
NHS Blackpool
NHS Blackburn with Darwen
NHS Central Lancashire
NHS East Lancashire
NHS North Lancashire
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The Nine Steps to Impact Assessment and Human Rights
Screening
Step 1
Complete Section 1
Please ensure that you consult the right people on the development of your policy,
procedure, strategy, project, function or service, commissioning and decommissioning
decision
Step 2
Complete Section 2 - identify what it is that you are impact assessing
Step 3
Gather data required e.g. service user uptake, Public Health data, research findings; health
needs assessments, complaints, patient experience feedback, staff surveys etc. and
assess the likely impact
Step 4
Undertake the Human Rights Screen and record your results (the screening tool is to be
found in the guidance notes)
Step 5
Complete Section 3: Impact Assessment and make a decision about the impact
against all Protected Characteristics – Make sure you include your rationale for the
decision – undertake the risk assessment in appendix 1
Step 6
If any high negative or adverse impacts are identified in Section 3 complete the Action
Plan in Section 4 with the support of the Diversity and Equality Team and
Consider alternative measures and include the risk score
Step 7
Complete Section 5 - Monitoring and review identifying how the Action Plan and Impact
Assessment decision/outcome will be monitored and reviewed within the Borough Council
and the Care Trust Plus
Step 8
Borough Council - Send your completed Impact Assessment to the Diversity and
Cohesion Manager
Care Trust Plus – send your completed Impact Assessments to the Diversity and
Equality Manager for Scrutiny in line with the Trust EIA Policy
Step 9
The Council and the Trust will publish the results of the Impact Assessments on the
Borough Council’s 'Policy Hub' and the CTP Website
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Section 1: Details
Manager or Sponsoring Directors
Name:
NHS Blackburn with Darwen, NHS Blackpool, NHS Central
Lancashire, NHS North Lancashire, NHS East Lancashire
Department/Directorate:
Public Health
Service:
Commissioning of health and healthcare
Assessment Lead:
Helen Lowey, Paula Wheeler and Julie Wall
Telephone:
01254 282000
E-mail:
Julie.wall@bwd.nhs.uk
Who else will be involved in
undertaking the impact
assessment:
How are you consulting with
people from different Protected
Characteristics
North West Public Health Policy Development Group
Five clinical engagement workshops with representatives form
the Acute Trust providers, Independent sector providers and
local PBC consortia groups took place during August and
September. These meetings focused on the clinical areas of
dermatology, ENT, Gynaecology, Orthopaedics and General
Surgery. The engagement process has to gathered evidence
via open dialogue with clinicians.
Clinical
Engagement#1 Attendees.doc
The project work undertook public engagement with people
from across Lancashire across a range of protected
characteristics during March 2011 – in total 14 public
engagement activities took place.
Who does the policy or decision
being made impact upon?
Signature:
Julie Wall
Service Users
Yes
No
Indirectly
Carers or family
Yes
No
Indirectly
General Public
Yes
No
Indirectly
Staff
Yes
No
Indirectly
Partner
organisations
Yes
No
Indirectly
Date:
21st February 2011
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Section 2: What is being assessed?
Name of ‘activity’:
Policy for Commissioning of Excision of Uterus (abdominal or
vaginal)
Implementation Date: April 2011
How was the need for the ‘activity’ identified?
The project group reviewed a range of procedures classified as low priority this being one of them.
This work is vital to ensuring that procedures commissioned by the Lancashire PCTs is appropriate
for the individual, is clinically effective as well as cost effective and meets NICE Guidance.
How is the activity meeting that need?
Throughout the review of the policies and the development of commissioning principles the project
group undertook extensive literature reviews of current research relating to clinical efficacy of the
policy and clinical engagement leading to the development of this policy.
What is the activity looking to achieve?
To set out a policy that meets NICE guidance and is in line with the Equality Act 2010 and the
Human Rights Act 1998.
The following evidence was considered in developing the policy:
Hysterectomy
NICE released guidance on heavy menstrual bleeding (HMB; menorrhagia) in 2007, where a comprehensive
review of the evidence, including cost effectiveness has been ascertained (NICE 2007a). The levonorgestral
intrauterine system (Mirena®) has been shown to be effective in the treatment of HMB. A Cochrane
systemic review concluded that levonorgestral intrauterine system / Mirena® coil improved the quality of
life of women with menorrhagia as effectively as hysterectomy. A number of effective conservative
treatments are available as second line treatment after failure of Mirena® or where it is contra-indicated.
Contra-indications to Merina® are:
 Severe anaemia, unresponsive to transfusion or other treatment.
 Distorted or small uterine cavity (with proven ultrasound measurements).
 Genital malignancy.
 Active trophoblastic disease.
 Pelvic inflammatory disease.
 Established or marked immune-suppression.
Hysterectomy should not be used as a first-line treatment solely for HMB and/or dysmenorrhoea (painful
menstruation), with or without fibroids (NICE, 2007). Evidence from NICE indicates that hysterectomy for
HMB and/or dysmenorrhoea may only be considered in accordance with the following criteria:
1. Other treatment options for HMB, dysmenorrhoea (and/or symptomatic large or multiple fibroids)
have failed, are contraindicated or are declined by the woman
AND
2. There is a wish for amenorrhoea (absence of menstruation);
AND
3. The woman (who has been fully informed) requests hysterectomy;
AND
4. The woman no longer wishes to retain her uterus and fertility.
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Women who are offered hysterectomy should be informed about the increased risk of serious
complications and the implications of the surgery (such as intra-operative haemorrhage or damage to other
abdominal organs, psychological impact, fertility impact etc.) associated with hysterectomy when uterine
fibroids are present. Whilst hysterectomy is an effective procedure for the treatment of HMB, it is
associated with more complications compared to treatment with progestogens.
In a study of long-acting reversible contraception, the costs of Mirena® were assessed. The total first-year
cost was £207, including consultation fees and the removal cost was £26. Because the average duration of
use was 3.2 years, the average annual cost to the NHS was found to be £70. Costing for treatment of HMB
is unlikely to differ greatly from these figures. This is compared to the cost of performing a hysterectomy as
being £2,362.
Local costing template produced to support the NICE guidance enables organisations such as primary care
trusts (PCTs) to estimate the impact locally and replace variables with ones that depict the current local
position. NICE has assumed a five year timeline from current practice to full implementation. A sample
calculation using this template showed that a PCT with a population of 300,000 could expect to incur
additional costs of £50,000 to manage women with HMB in accordance with NICE guidelines (NICE, 2007b)
What are the aims and objectives?
This policy provides a framework for commissioning Excision of Uterus (abdominal or
vaginal) for people with Menorrhagia, heavy menstrual bleeding (HMB).
.
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Section 3: Impact Assessment
Group
Does the ‘activity’ have
the potential to:
Positive
(Y/N)
Y
Negative
(Y/N)
N
 Have a positive
impact (benefit) on
any of the groups?
Explain how
 Have a negative
impact / exclude /
discriminate against
any person or group?
Explain how this was
identified? Evidence/
Consultation?
Reasons for decision
There is no evidence that this policy will impact
negatively on people of different ages, however
the policy allows for exceptions as set out below:
7.3 The Commissioning Organisation will
consider exceptions to this policy. This
policy is based on criteria of
appropriateness, effectiveness, cost
effectiveness and ethical issues. A
successful request to be regarded as an
exception is likely to be based on
evidence that the patient differs from the
usual group of patients to which the
policy applies, and this difference
substantially changes the application of
those criteria for this patient. Requests
for funding for hysterectomy (vaginal or
abdominal) under exceptional
circumstances may be submitted to the
Commissioning Organisation’s
Individual Funding Request Panel. (See
Policy for Individual Funding Requests
for guidance on exceptionality and
application process.)
Age
N
Disability
Don’t
know
N
Guidance
Please refer to the
guidance notes
NB: Requires
(existing or new)
consultation with
‘relevant’ people who
are from these
groups or who have
knowledge insight
into these groups.
N.B. Marriage & CP
is only protected in
terms of work-related
activities NOT
service provision
(please refer to
guidance notes)
There is no evidence that this policy will impact
negatively on people who have a disability,
however the policy does allow for exceptions and
disability issues could be considered on a case
by case scenario
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Marriage &
Civil
Partnership
Pregnancy
and maternity
N/A
N/A
N
N
N
N
N
N
There is no evidence that this policy will impact
negatively on people who have differing religions
and beliefs.
Y
Possible
The policy is in relation to excision of the uterus
and therefore if the policy is followed accordingly
by clinical staff as part of ensuring patients
informed choice there will be a positive impact to
this protected group.
Race
Religion or
belief
N/A
N/A
The policy is in relation to excision of the uterus
and therefore if the policy is followed accordingly
by clinical staff as part of ensuring a patients
informed choice there will be no impact to this
protected group.
There is no evidence that this policy will impact
negatively on people of different races.
Sex
There is a potential for indirect negative impact if
the policy is applied in a blanket approach
however impact assessments should be
undertaken on each funding decision to eliminate
or proportionately justify the indirect
discrimination.
There is no evidence that this policy will impact
negatively on people who have differing sexual
orientations.
Sexual
orientation
N
Gender
reassignment
N
There is no evidence that this particular policy
will impact negatively on people who are
Transgendered, however where the service user
is a female to male (F2M) Transgendered person
the removal of the uterus would come under the
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commissioning of Gender Reassignment policy.
N
N
There is no evidence that this policy will impact
negatively on people who are from vulnerable
groups.
N
N
There is no evidence that this policy will impact
negatively on people who are from deprived
communities.
N/A
N/A
Vulnerable
Groups
Deprived
Communities
Carers
N/A
N/A
Other
(please state)
Does the ‘activity’ raise
any issues for
Community Cohesion?
Does the ‘activity’ raise
any issues in relation to
Human Rights as set out
in the Human Rights
Act 1998
No evidence to suggest the application of this policy will impact on community cohesion at this
current juncture.
See the Guidance notes
If the policy positively
impacts some groups and
negatively impacts or
overlooks other sections
of the community, what
effect will this have on the
relationship between
these groups? How will
you manage this
relationship?
The principles document and associate policies set out to test the appropriateness, effectiveness, See the Guidance
Notes
cost effectiveness and ethical rationale of the clinical intervention/healthcare provision.
These are blanket principles and policies, which have the potential to negatively impact/engage a
person’s human rights.
1.
Basic Human Rights
Screening Tool.doc
the principles document has been through the basic human rights screening
as attached. The Principle document appears to apply the Human rights principles of Dignity
and respect.
It is important to
note that if the
decision removes or
engages a persons
absolute rights the
policy/decision will
need to be changed.
Where it is a Limited
or Qualified Right the
decision needs to be
proportional and
legal.
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What is the overall cost
of implementing the
‘activity’?
Cost & Source(s) of funding
The policy considers cost effectiveness as one of the four tests carried out to determine the
effectiveness of a clinical intervention/health care provision, there is a potential underlying cost
saving.
In relation to the current economic climate there is a rationale for ensuring that all NHS healthcare is
in line with NICE Guidance and Clinical evidence base/efficacy, these principles provide the rationale
for taking fair and objective financial decisions around healthcare commissioning decisions.
6. What are the
benefits?
What targets/indicators
will be used to measure
these?
Failure to apply the principles in a fair and objective way considering the needs of people from
different protected groups in line with the Equality Act 2010 can have serious financial implications for
the Trusts e.g. cost of Judicial Reviews, Litigation, Legal fees, non-compliance notices etc.
Benefit
Indicator
1. Service users should receive treatments
which are effective and ethical
2. Trusts can apply fair criteria to
commissioning decisions around
funding health care and clinical
procedures
3. Trusts remain compliant with Equality
and Human rights legislation
Impact Assessment Risk If the criteria are applied as above
considering Equality and Human rights
Score See Appendix 1
Score = 6 moderate
1. No complaints from service users, their
representative or local community groups
representing protected groups.
2. No judicial reviews
3. Documented evidence of commissioners
applying the principles and considering
protected groups
Input cost e.g.
Financial investment,
HR, to realise and
achieve benefits of
the activity
Source – e.g.
specific funding
stream, pooled
budget or
mainstream budget
For example
 National
Indicators
 Equality
Framework - LA
 Local Indicators
 BVPI’s
 EPIT – Equality
Tool for NHS
 Care Quality
Commission
(CQC) Outcomes
4. All decisions are impact assessed with
through analysis of equality data provided
by Public Health, Diversity and Equality
Leads as well as the clinical effectiveness
and cost effectiveness data.
5. PCTs score does not show a backward
trend on NHS North West’s EPIT Goal 2, 3
and 4
Actions to minimise Risk
Ensure that D&E is embedded into the application of the principles
not just the appropriateness, effectiveness, cost effectiveness and
Page 9 of 14
If not
Score = 15 high
ethics and consider each individual case in line with the Equality Act
2010 and Human Rights Act 1998
Section 4: Action Plan
What is the
negative
impact?
Lack of
engagement with
people of different
protected groups
n developing the
principle
document and
associate policies
Risk Score
current
15
Actions required to reduce/eliminate the negative impact
target
6
1. To undertake engagement with people from protected groups
as part of the development phase of these principles and
policies in line with the Equality Act 2010 and current and
future Equality Duties – consultation is not sufficient at the end
2. To demonstrate what changes/equality of outcomes (if any)
the engagement has brought about to the principles and
policies.
Resources
required
(see
guidance
note below)
?Funding for
engagement
activities
Piggy back on
to existing
engagement
activity
Who will
lead on
action?
Target
completion
date
Project
group
supported
by D&E
leads in
each PCT
Completed
and risk
reduced to
6
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* ‘resources required’ is asking for a summary of the costs that are needed to implement the changes to mitigate the negative impacts identified.
Section 5: Monitoring and Review
Monitoring
The responsibility for establishing and maintaining the monitoring arrangements of the EIA action plan lies with the service completing the EIA. These
arrangements should be built into the performance management framework.
The Impact Assessment action plan will also be visible at a corporate level through the scrutiny and sign off of the EIA summary by the Equality and
Cohesion Manager.
Monitoring arrangements for Impact Assessments and there subsequent action plans will be achieved at a strategic level, through the Management
Accountability Framework (MAF), carried out by all Heads of Service in the Borough Council and through the Strategic Equality and Diversity Group in
the Care Trust Plus.
Please describe briefly, how the
action plan will be monitored?
This Action plan was monitored via the project group and the Pan Lancashire PCT’s D&E meeting.
E.g.
Via MAF,
Monitored by departmental E&D
group
Strategic D&E Group - NHS
Review
The responsibility for establishing and maintaining the review arrangements of the Impact Assessment and the action plan lies with the service
completing the Impact Assessment.
Date of the next review of the Impact Assessment?
It should be reviewed at least every three years to meet
legislative requirements
February 2012
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How often will the EIA action plan be reviewed? E.g.
Quarterly as part of MAF or as part of D&E Strategy Group
in NHS
Who will carry out this review?
If there are any changes to the current policy the EIA will be reviewed as part of the
changes.
The Project team responsible for the development of the policy and the D&E Leads
across the Lancashire PCT Cluster
Signature of person completing the Impact Assessment:
Signature of Head of Equality, Diversity & Human rights:
………
Date Completed: ………………
Signature of Head of Service/directorate Lead:
………………………
Julie Wall - countersigned by: Dianne Gardner NHS East Lancashire
Date Received: 21st February and March 31st 2011
Date Completed: …………………
Page 12 of 14
Appendix I - Impact Assessment Risk Grading
Severity score
1
Insignificant
2
Minor
Insignificant cost increase /
schedule slippage. Barely
noticeable reduction in
scope or quality
Minor injury not requiring
first aid
<5% over budget /
schedule slippage. Minor
reduction in scope or
quality
Minor injury or illness. First
aid treatment needed
5-10% over budget /
schedule slippage.
Reduction in scope or
quality
RIDDOR / Agency
reportable
Unsatisfactory patient
experience not directly
related to patient care
Locally resolved complaint
Unsatisfactory patient
experience – readily
resolvable
Justified complaint
peripheral to clinical care
Mismanagement of patient
care
Service / Business
Interruption
Staffing and
Competence
Loss / interruption up to 1
hour
Short term low staffing
level temporarily (<1 day)
reduces service quality
Loss / interruption up to 8
hours
Ongoing low staffing level
reduces service quality
Financial
Loss <1% of budget
Potential cost
Inspection / Audit
Up to £10K
Minor recommendations.
Minor non-compliance with
standards
Loss 0.1 to 0.24% of
budget
£10,000 - £25,000
Recommendations made.
Non-compliance with
standards
Adverse Publicity /
Reputation
Contained within the
organisation. Rumours
Descriptor
Objectives / Projects
Injury
Patient Experience
Local media – short term.
Minor effect on staff
morale
3
Moderate
Below excess claim.
Justified complaint
involving lack of
appropriate care
Loss / interruption up to 1
day
Late delivery of key
objective / service due to
lack of staff. Minor error
due to poor training.
Ongoing unsafe staffing
level
Loss 0.25 to 0.49% of
budget
£0.25m - £0.5m
Reduced rating.
Challenging
recommendations. Noncompliance with core
standards
Local media – long term.
Significant effect on staff
morale
4
Major
5
Catastrophic
10-25% over budget /
schedule slippage. Does
not meet secondary
objectives
Major injuries or long term
incapacity / disability (loss
of limb)
Serious mismanagement
of patient care
>25% over budget /
schedule slippage. Does
not meet primary
objectives
Death or major permanent
incapacity
Claim above excess level.
Multiple justified
complaints
Totally unsatisfactory
patient outcome or
experience
Multiple claims or single
major claim
Loss / interruption up to 1
week
Uncertain delivery of key
objective / service due to
lack of staff. Serious error
due to poor training
Permanent loss of service
or facility
Non-delivery of key
objective / service due to
lack of staff. Loss of key
staff. Critical error due to
insufficient training
Loss 0.5 to 0.99% of
budget
£0.5m - £1m
Enforcement action. Low
rating. Critical report.
Major non-compliance with
core standards
Loss >1% of budget
National media up to 3
days
National media >3 days.
MP concerns (Questions in
the House)
£1m plus
Prosecution. Zero rating.
Severely critical report
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2 – likelihood score
Descriptor
Frequency
Probability
1
Rare
Not expected to occur
for years
<1%
Will only occur in
exceptional
circumstances
2
Unlikely
Expected to occur
at least annually
1-5%
Unlikely to occur
3
Possible
Expected to occur
at least monthly
6-20%
Reasonable chance
of occurring
4
Likely
Expected to occur
at least weekly
21-50%
Likely to occur
5
Almost Certain
Expected to occur
at least daily
>50%
More likely to
occur than not
4
4
Moderate
8
Significant
12
Significant
16
High
20
High
5
5
Moderate
10
Significant
15
High
20
High
25
High
1 (severity) x 2 (likelihood) = total risk score and rating
Likelihood
1
2
3
4
5
1
1
Low
2
Low
3
Low
4
Moderate
5
Moderate
2
2
Low
4
Moderate
6
Moderate
8
Significant
10
Significant
Severity
3
3
Low
6
Moderate
9
Significant
12
Significant
15
High
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